Novartis Pharmaceuticals Canada recently announced that Health Canada has issued a Notice of Compliance (NOC) for RHAPSIDO (remibrutinib tablets) for the treatment of Chronic Spontaneous Urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. The decision is supported by the phase 3 REMIX-1 and REMIX-2 double-blind, randomised, placebo-controlled studies.

Dr. Vipul Jain, Allergist and Clinical Immunologist, said, "Every person with Chronic Spontaneous Urticaria is different, so having more treatment options is important. A fast, convenient, needle-free treatment that can help with both hives and swelling could make a meaningful difference in my patients' daily lives. This is exciting news for both patients and the clinicians who care for them."

Research has shown that activation of Bruton Tyrosine Kinase (BTK) triggers the release of histamine and other proinflammatory mediators that contribute to the symptoms of CSU. Phase 3 clinical trials support the efficacy of RHAPSIDO (remibrutinib tablets) to selectively inhibit BTK, resulting in improvements from baseline in Urticaria Activity Score (UAS7) at week 12.

Dana Gies, Executive Director, Canadian Skin Patient Alliance (CSPA), said, "CSU patients often face uncertainty every day, never knowing when symptoms may flare or how they will affect their plans, work, or family life. Any advancement that expands treatment options for this community is welcome news and reinforces the importance of continuing to address unmet patient needs."  

CSU is characterised by itch, hives and/or angioedema persisting for more than 6 weeks without an identifiable cause. CSU can place a significant physical, emotional, and social burden on patients, potentially leading to sleep disturbances, fatigue, pain, stigma, and profound impacts on mental well-being, relationships, and quality of life.

Dimitri Gitas, Country President, Novartis Canada, said, "This approval represents meaningful progress for Chronic Spontaneous Urticaria patients and reflects our ongoing commitment to bringing innovative medicines to those who need them most. We are proud to continue advancing immunology research and addressing patients' most pressing unmet needs."